IRB Definitions

An event that occurs during the course of a research protocol that either causes physical, social, economic, or psychological harm, or increases the risk of physical, social, economic, or psychological harm, or results in loss of privacy and/or confidentiality to a research participant or others (i.e. family members). Adverse events include expected and unexpected harmful effects and unexpected harms of an interaction or an intervention.

For more information on adverse events, see the Reportable Events and Non-Compliance page.

Alteration refers to altering some or all of the elements in the informed consent process, such as use of deception. 

To qualify for an alteration of consent, investigators must address how the project meets each of the following criteria: 

• The research involves no more than minimal risk to the subjects;
• The research could not practicably be carried out without the requested alteration;
• If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format;
• The alteration will not adversely affect the rights and welfare of the subjects; and
• Whenever appropriate, the subjects or legally authorized representatives will be provided with additional pertinent information after participation.

For more information on the different waivers of consent, see the What are Waivers resource. 

Anonymous means there is no way for researchers or any other party to link data from an individual participant back to that specific participant either directly or indirectly. This would mean that no direct identifiers are collected, such as name, Social Security number, or any audio or video recordings. Additionally, there will not be a key linking personally identifiable information to participant pseudonyms or random identifiers.

• Example: An online survey might be anonymous, so long as it does not collect IP addresses or any direct identifiers, such as name or Social Security number.
• However, keep in mind that even if no direct identifiers are collected, if the sample size is small enough or not very diverse, it is possible that data may still be identifiable.
  • Example: An investigator collects survey data, including gender identity, from a company of 30 employees. The sample includes one person who identifies as a man. 

A study that is closed to enrollment will not recruit or consent any additional participants for the study in the future.

A co-investigator is anyone who will actively engage with human subjects and/or will have access to identifiable human subject information. This includes individuals who may assist in consenting participants, collecting participant data, or analyzing identifiable participant data for the study. All co-investigators must be listed on the IRB Application and their completed CITI Training must be included in the submission.

Compensation is offered to participants in exchange for the time they spend participating in the research study. Examples of compensation include cash, a gift card, extra credit in a course, food, or some other small gift such as a book or a toy. If you wish to use alternative methods for compensating participants, it is recommended that you consult with the IRB Office.

Confidentiality refers to how researchers handle and protect data from participants. This includes the expectation that individual responses will not be shared in conjunction with a participant’s identity beyond the research team unless they have agreed otherwise in writing (such as in the informed consent form).

• In thinking about confidentiality, investigators should consider:
  • How data will be stored securely
  • Who will have access to the data, especially identifiable data
  • How long identifiable data (such as audio/video recordings, the key linking personally identifiable information to pseudonyms/codes, signed consent forms) will be stored
• Please note that confidentiality cannot be guaranteed. For example, an investigator cannot guarantee that focus group participants will not share what other participants said outside of the focus group session.
• Additionally, there are some circumstances in which investigators would be required to breach confidentiality, such as if child abuse or neglect is reported by a participant. 

Deception is intentionally providing inaccurate or false information to participants. For more information on what is considered deception and what to include in a study with deception, refer to the Deception Resource.

To de-identify data is to remove any personally identifiable information. This is usually performed so that the data can be retained for analysis purposes, reducing the risk of breach of confidentiality. After de-identification, there may or may not be a way to link de-identified data back to identifiable information (e.g. through a key that links participant names to pseudonyms/study IDs). For information on how to de-identify Protected Health Information, refer to the OHRP Guidance Regarding Methods for De-Identification.

Any difference in study conduct from the criteria or activities prescribed in the IRB approved protocol, which may or may not affect the participants' rights, safety, welfare, and/or the integrity of the study.

For more information on protocol deviations, see the Reportable Events and Non-Compliance page.

A full waiver of consent is when an individual will not be approached for consent or it is not possible to approach an individual for consent such as in a secondary data analysis. 

To qualify for a full waiver of consent, investigators must address how the project meets each of the following waiver criteria:

• The research involves no more than minimal risk to the subjects;
• The research could not practicably be carried out without the requested waiver;
• If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format;
• The waiver will not adversely affect the rights and welfare of the subjects; and
• Whenever appropriate, the subjects or legally authorized representatives will be provided with additional pertinent information after participation.

For more information on the different waivers of consent, see the What are Waivers resource. 

The University of Maryland is a Hybrid Entity under the HIPAA Privacy Rule. This means we are allowed to have covered and non-covered functions. The University Health Center and the Hearing and Speech Clinic are covered entities under HIPAA. The Health Center must work with other units on campus where it might be necessary to disclose PHI to these units in order to carry out its health care function. These units are defined as business associates under HIPAA and must comply with requirements to ensure the safeguarding of protected health information. General Counsel, Chief Information Security Officer, and the HIPAA Privacy Officer are considered business associates. For more information, click here.

Research

Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

• Systematic investigation: using a methodological approach to an activity. This usually involves a hypothesis, a research question, and a plan to systematically collect and analyze data. Note that the absence of a hypothesis does not automatically  mean an activity is not a systematic investigation.
• Developing or contributing to generalizable knowledge: designed with the intent of sharing the findings with others (e.g. via publication or presentation).

There are also four specific types of activities that are deemed not to be research:

• Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship) that focus on information specifically about certain individuals.
• Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority.
• Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
• Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.

Examples of projects that may not be considered research:

• Oral history projects where investigators intend to use the findings only to document or report on events or situations without the intent to form hypotheses, draw conclusions, or generalize findings outside the sample. These projects are not considered human subjects research and thus would not require IRB approval.
  • However, oral history projects that intend to develop generalized knowledge (e.g. using findings to describe human beliefs or behaviors in a specific cultural setting or draw conclusions to influence public policy or decisions) do require IRB approval. If they are human subject research, oral history projects generally are exempt. 
     
• Quality assurance/quality improvement projects where data are collected systematically but without the intention of sharing the information with others (contribute to generalizable knowledge).
  • However, if investigators intend to publish the results of a quality assurance/improvement project prior to the initiation of data collection, then the project should be submitted to the IRB via an Initial Application.
     

Human Subject

Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains:

i) Information or biospecimens through intervention or interaction with the individual; OR

ii) Identifiable private information or identifiable biospecimens.

Intervention: Includes both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.

Interaction: Includes communication or interpersonal contact between investigator and subject. The interaction may take place verbally, in writing, or electronically.

Private information: Includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record).

Identifiable private information: Is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.

Identifiable biospecimens: Is a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.

The active process by which the investigator shares information with the prospective subject, including: (1) disclosing to potential research subjects information needed to make an informed decision; (2) facilitating the understanding of what has been disclosed; and (3) promoting the voluntariness of the decision about whether or not to participate in the research. The general requirements for informed consent reflect this. Consent must be appropriately documented or a waiver of consent documentation, alteration of consent, or full waiver of consent must be requested.

Please Note: Consent is not simply a document – it is an ongoing process; a continual discussion with the research participant. Participation is always voluntary and participants may stop at any time. Participants may ask questions before signing, during the study, and after the study has been completed.

A study that is open to enrollment is actively recruiting and consenting participants now and in the future.

Oral history is typically defined as a method of gathering, preserving and interpreting the voices and memories of people or communities in past events through recorded interviews. Often, oral history projects do not require IRB review because they do not seek to contribute to generalizable knowledge and therefore, are not considered research per the federal regulations governing the IRB process.

The Code of Federal Regulations states that oral history is not human subject research at 45CFR46.102(l)(1): For the purposes of this part, the following activities are deemed not to be research:

• Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.

If you are unsure as to whether a project qualifies as oral history, or if IRB review is required, please complete the Human Subject Research Determination Form in Kuali-IRB. For more information, see the Transition to Kuali-IRB page.

Enrolled participants include the total number of participants who have consented to participate in the research, regardless of whether the participants complete the research in its entirety or provide invalid responses.

Participant withdrawals occur when participants who have consented to participate in the research do not complete the research in its entirety, or request to have their data removed from the research.

• Example: A participant clicked “I consent” when filling out an online survey but the individual did not complete the survey in its entirety or, they provided invalid responses (i.e. – They marked “A” for every response).  
• Example: A research study included the element of deception. At the end of the study, the researchers debriefed the participants, informing them of the deception. A participant requested to have their data removed from the study after learning of the deception.
• Example: A research study asked students to complete 5 surveys at different timepoints throughout the semester. Some students completed one or two of the surveys, but neglected to complete all 5 surveys.  

Personally identifiable information is any direct or indirect personal information that can link a participant to a research study.

• Examples of PII UMD investigators might collect:
  • Full names
  • Addresses
  • Personal identification numbers such as social security number, passport number, driver’s license number, taxpayer identification number
  • Dates (e.g., birthdate, date of death, etc.)
  • Phone numbers
  • E-mail addresses
  • Audio recordings
  • Video recordings
  • Full face photos
  • IP addresses
  • A “key” or “master list” that links de-identified data to identifiers

Protected Health Information is any individually identifiable health information collected or created as result of the provision of health care by a covered entity, past, present or future. PHI can include a medical record, a laboratory report, or a hospital bill. UMD is a hybrid entity. The University Health Center and the Hearing and Speech Clinic are covered entities under HIPAA.

Protocols may receive one of two risk classifications:

• Minimal Risk is defined per the Code of Federal Regulations as: “the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of a routine physical or psychological examinations or tests” [45 CFR 46.102(j)].
• Greater than Minimal Risk is defined as research that does not meet the above definition of Minimal Risk.

Unanticipated problems are defined as any incident, experience or outcome that meets all of the following criteria:

• Unexpected (unforeseen by the researcher or the research participant) in terms of nature, severity, or frequency, given the research procedures and the subject population being studied;
• Related or probably related to participation in the research, or if the event or problem probably or definitely affects the safety, rights and welfare of current participants;
• Suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic or social harm) than was previously known or recognized.

The Office of Human Research Protections' (OHRP) also has a video on the difference between adverse events and unanticipated problems: Reporting to OHRP (1): Unanticipated Problems

For more information on unanticipated problems, see the Reportable Events and Non-Compliance page.

A group of individuals with diminished autonomy who require additional protections. For example, minors must have parental consent to participate. Examples of vulnerable populations: children, pregnant women, prisoners, cognitively impaired, illiterate, etc.

For information regarding prisoner research, please visit the Office of Human Research Protections' (OHRP) webinars listed below:

• Prisoner Research 1: 45 CFR 46 Subpart C-Basics
• Prisoner Research 2: Considerations When a Subject Becomes a Prisoner

A waiver of consent documentation is when a participant provides verbal consent or clicks a button or checks a box to indicate consent, or in the case of research studies with children, when there will be an opt-out process for the parents.

To qualify for a waiver of consent documentation investigators must address how the project meets any of the following criteria:

• That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context;
• That the only record linking the subject and the research would be the informed consent form and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject (or legally authorized representative) will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; or
• If the subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained.

In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects or legally authorized representatives with a written statement regarding the research.

For more information on the different waivers of consent, see the What are Waivers resource.